K942638 is an FDA 510(k) clearance for the SIMULTRAC LH/FSH RADIOUMMUNOASSAY KIT. This device is classified as a Radioimmunoassay, Luteinizing Hormone (Class I - General Controls, product code CEP).
Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Orangeburg, US). The FDA issued a Cleared decision on September 7, 1994, 96 days after receiving the submission on June 3, 1994.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1485.
| 510(k) Number | K942638 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 03, 1994 |
| Decision Date | September 07, 1994 |
| Days to Decision | 96 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | CEP — Radioimmunoassay, Luteinizing Hormone |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.1485 |